Cutaneous Lupus Medication Experience Study

NCT02176148 | Completed FDA Drug

• 1 other identifier: IRB00026573
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Cutaneous lupus is a chronic, relapsing, auto-immune skin disease that can have many presentations. Its effect on physical appearance greatly affects patients' quality of life. In addition, 10% of patients with cutaneous lupus will develop systemic lupus. Topical therapies are the mainstay of cutaneous lupus treatment; however patients often find these treatments to be messy, inconvenient, or ineffective. In addition, for more severe disease patients are often placed on concurrent systemic therapies. The primary hypothesis of our study is that poor adherence contributes to poor treatment outcomes in patients with cutaneous lupus.

Conditions

Cutaneous Lupus

Keywords

cutaneous lupus; systemic lupus; systemic therapy; medication

Outcome Measures

Primary Outcomes (1)

• Change in Adherence Measures

  There will be interim measures taken after the baseline measure at month 1, month 3, and at end point month 6.

  up to 6 month

Secondary Outcomes (1)

• Disease Severity Measures

  6 months

Study Arms (1)

Lupus control standard-of-care

Each person enrolled will be given fluocinonide 0.05% cream to apply twice daily to active areas.

Drug: fluocinonide 0.05% cream

Interventions

fluocinonide 0.05% cream DRUG

Lupus control standard-of-care

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dermatology clinic patients with a diagnosis of active cutaneous lupus confirmed by a dermatologist

You may qualify if:

• Any male or female 12 years or older of age with a diagnosis of cutaneous lupus by a dermatologist
• Capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed
• Able to complete the study and comply with study instructions, including attending all study visits

You may not qualify if:

• Individuals younger than 12 years of age
• Known allergy or sensitivity to study medication
• Inability to complete all study-related visits
• Introduction of any other prescription medication, topical or systemic, for cutaneous lupus while participating in the study

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University School of Medicine - Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

Fluocinonide

Intervention Hierarchy (Ancestors)

Fluocinolone Acetonide; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• William W Huang, MD, MPH, FAAD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: December 1, 2014
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

US (1)